VIA - The VIA procedure kit - custom includes transport - US Endoscopy

Duns Number:627879687

Device Description: The VIA procedure kit - custom includes transport pad, gauze pads, biohazard sticker, sol The VIA procedure kit - custom includes transport pad, gauze pads, biohazard sticker, solidifier, Via basin, enzymatic sponge, lubricating jelly, suction tubing, Double Header cleaning brush, and BioShield biopsy valve.

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

00717210

Brand Name

VIA

Version/Model Number

00717210

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 15, 2020

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

NWU

Product Code Name

Endoscope introducer kit

Device Record Status

Public Device Record Key

804a3bc8-a157-42e8-9f7e-5d468b93fbbd

Public Version Date

January 15, 2020

Public Version Number

2

DI Record Publish Date

July 02, 2019

Additional Identifiers

Package DI Number

10816765015831

Quantity per Package

18

Contains DI Package

00816765015834

Package Discontinue Date

January 15, 2020

Package Status

Not in Commercial Distribution

Package Type

Case

"US ENDOSCOPY" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 51
2 A medical device with a moderate to high risk that requires special controls. 902